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Completed

NCT Number: NCT00185900

Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Completed

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Key information

Conditions

Obstetric Labor, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

:- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

Treatment and study plan

Magnesium sulfate

Drug

Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

nifedipine

Drug

Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Primary outcomes

  1. Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence

    Time frame: 48 hours after administration of study medication.

    Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.

Secondary outcomes

  1. Time to Uterine Quiescence

    Time frame: Until delivery, up to 42 weeks of gestation

    Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.

  2. Gestational Age at Delivery

    Time frame: Until delivery, up to 42 weeks of gestation

    Presented as weeks

  3. Neonatal Birth Weight

    Time frame: Until delivery, up to 42 weeks of gestation

    Presented as grams

  4. Serious Maternal Adverse Effect

    Time frame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery.

    A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.

  5. Composite Neonatal Morbidity

    Time frame: From delivery until discharge from the hospital, up to 30 days of age

    Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
1999
Primary completion
2005
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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